Clinical trial · Observational
Cancer Risk Assessment in Patients With a Constitutional Alteration of the PTEN Gene
National Cohort of Patients With Cowden's Disease and With a Constitutional Alteration of the PTEN Gene for the Prospective Assessment of the Risk of Cancer.
NCT05630105CI-TRIAL-00111736COCOsuspendedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Cyber attack of the enrollment system, new system on going to be implemented
Summary
Brief summary (as posted)
This is a multicentric, observational, retrospective and prospective study, aiming to estimate the risk of cancer occurrence in subjects carrying a PTEN mutation, based on the constitution of a national cohort.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PTEN Gene Mutation | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of subjects with a cancer event
- timeFrame
- From date of identification of a constitutional alteration of the PTEN gene until the date of first cancer event or date of death from any cause, whichever came first, assessed up to 20 years.
- description
- Number of subjects with a cancer event (any cancer) observed in the population of subjects presenting a constitutional alteration of the PTEN gene.
Secondary outcomes (6)
- measure
- Number of subjects with a breast cancer event
- timeFrame
- From date of identification of a constitutional alteration of the PTEN gene until the date of first breast cancer event or date of death from any cause, whichever came first, assessed up to 20 years.
- description
- Number of subjects with a breast cancer event (any cancer) observed in the population of subjects presenting a constitutional alteration of the PTEN gene.
- measure
- Number of subjects with a thyroid cancer event
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Male or female. 2. Adult or child without age limit. 3. Carrier of a constitutional or mosaic alteration of the PTEN gene established and/or confirmed by the Institut Bergonié's genetics laboratory, following a request for molecular diagnosis made between 1997 and 2027. 4. Participant informed of his genetic diagnosis. 5. Participant informed and not having expressed non-opposition to participate in the research. 6. Participant affiliated to a French social security system in accordance with French law on research involving the human person. Exclusion Criteria: 1. Participant under guardianship or curatorship. Exception: a participant with autism may be included in the study. 2. Persons deprived of their liberty by a judicial or administrative decision. 3. Persons under psychiatric care, persons admitted to a health or social establishment for purposes other than research; Exception: a participant with autism may be included in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.